PTSM: Pharmaceutical Technology Sourcing and Management, Jul 9, 2008 - Pharmaceutical Technology

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PTSM: Pharmaceutical Technology Sourcing and Management, Jul 9, 2008
Global Feature
The Economics of Follow-on Biologics
By Patricia Van Arnum
A recent US government study shows that follow-on biologics are likely to have a favorable economic impact if proposed legislation authorizing a regulatory pathway in the US is approved.
Information Technology and Software
Enterprise-Level Change Control
By Matthew Kopecky
Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control.
Outsourcing
Toward a New Model for Contract Manufacturing
By Jim Miller
Global manufacturing excellence will be a game changer for CMOs that can achieve it.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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